Health Canada — Medical Devices · Canada · 2025-08-14 · Type II
As described by Health Canada — Medical Devices: Merit basixCOMPAK™, PhD™ Hemostasis Valve, and basixSKY™ Inflation Syringe
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Cardiovascular - General hospital and personal use
Product type
Medical devices
Reported risk: Merit Medical became aware of a manufacturing defect after an increased number of complaints. Investigation into the issue concluded that the lack of fluorinated silicone in the bleed back seal (the secondary valve) caused by the mix of incorrect silicone during production line influenced the performance of the PhD™ Hemostasis Valve. The lack of silicone was found to prevent the secondary valve from releasing and closing properly. The valve cap potentially would remain depressed causing leakage. Recall start date: July 30, 2025
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